MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.
[183275393]
It was indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183275514]
It was reported that the patient experienced a pericardial effusion. During an ablation procedure with an intellanav mifi open-irrigated catheter, a non-boston scientific sheath and a non-boston scientific coronary sinus (cs) catheter, the physician went transseptal so he could map the left atrium (la) for atrial fibrillation ablation. This was the physician's first left sided case with the intellamap orion mapping catheter, but he had a physician proctor. The physician had trouble getting into one of the veins, so he decided to do a second transseptal later in the case. They started burning the anterior wall and moved to the posterior wall. While burning the esophageal, the temperature monitor started beeping and one of the laboratory staff looked at the pressure on the anesthesia monitor and "asked if it was real. " using intracardiac echocardiogram (ice), it was discovered that the patient had a pericardial effusion and the staff performed a pericardiocentesis. The procedure was completed successfully. The cs catheter and the intellanav mifi oi catheter were in the body at the time of the adverse event. No resistance was felt while maneuvering the catheters. It was reported that the patient was "okay. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03119 |
| MDR Report Key | 9825416 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH DC A330 |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
| Manufacturer City | LA AURORA - HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLANAV MIFI OPEN-IRRIGATED |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-03-12 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0023897977 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |